I am pleased to report that our proposal to the National Institutes of Health (NIH), 1U01 DK 119102 - 01, “Integrated Clinical and Research Systems for Diabetic Foot Wound Care,” has been awarded by the National Institute of Diabetes and Digestive and Kidney Diseases. With this 4-year U01 award, we join a select group of academic institutions in a clinical research consortium that aims to study biomarkers for diabetic foot ulcer healing. This award leverages the clinical expertise of our new UPMC Wound Healing Service line and the scientific power of the University of Pittsburgh.

Diabetes is a common, complex, and costly disease affecting 9.4% (30.3 millions) of Americans. It remains the 7th leading cause of death in the United States, contributing to over 250,000 deaths annually. Diabetic foot ulcers (DFU) are the most frequently recognized complication in diabetics with an incidence of 6% in the diabetic global population, 6% among Medicare diabetic beneficiaries, 5% among diabetic U.S. veterans, and a lifetime incidence of foot ulcers between 19% and 34% in all diabetics. The natural history of a diabetes-related foot ulcer is devastating. More than half of ulcers become infected and approximately 20% of moderate or severe diabetic foot infections lead to amputation. Mortality after DFU-related amputations is greater than 70% at 5 years, which is 2.5 times higher than in diabetic patients without a foot ulcer.

Our wound healing clinical research team will be embedded within 3 sites in the UPMC Wound Healing Services network and will systematically collect and analyze data that can be potentially useful for predicting the severity and prognosis of diabetic foot ulcers. The data will be correlated with the clinical course of healing, and rigorous, evidence-based clinical pathways followed in order to standardize treatment. Our clinical providers and consultants across numerous disciplines will help evaluate and refine the treatment pathways. Importantly, we will address the major challenges of diabetic foot ulcer clinical research through the seamless integration of wound center clinical operations and research operations. We will be implementing research recruiting and research conduct practices that allow us to learn from our diverse patient population while maintaining high clinic efficiency and outstanding care. This is a tremendous team effort, with a multidisciplinary approach and unique partnership involving the clinical care providers, the researchers, and our data systems experts.

This NIH award helps put our new service line on a path to important contributions in the field of wound healing and I sincerely thank all of you for your collaboration. It is only with your expertise that we can establish this unique effort and evolve new standards.

J. Peter Rubin

McGowan Institute for Regenerative Medicine affiliated faculty members Lauren Kokai, PhD (pictured center), research faculty member in the Department of Plastic Surgery, School of Medicine, and co-director of the Adipose Stem Cell Center at the University of Pittsburgh, and MaCalus Hogan, MD (pictured bottom), Vice Chair of Education and Residency Program Director in the Department of Orthopaedic Surgery at UPMC, and Assistant Professor in the Departments of Orthopaedic Surgery and Bioengineering at Pitt, are members of the research team working on this project.